Cleared Traditional

Mesh Nebulizer (H6)

K251659 · Qingdao Future Medical Technology Co., Ltd. · Anesthesiology

Nov 2025

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K251659 is an FDA 510(k) clearance for the Mesh Nebulizer (H6), a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Qingdao Future Medical Technology Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on November 14, 2025, 168 days after receiving the submission on May 30, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K251659 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2025
Decision Date	November 14, 2025
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF